Trial record 2 of 2 for:    11157

Radiation and Androgen Ablation for Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01517451
First received: January 20, 2012
Last updated: January 28, 2016
Last verified: January 2016
  Purpose
A study to see how effective and tolerable radiation therapy along with androgen deprivation therapy is in treating prostate cancer.

Condition Intervention Phase
Adenocarcinoma of the Prostate
Radiation: Radiation Therapy
Drug: Androgen Deprivation Therapy (ADT)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stereotactic Body Radiation Therapy and Short-Term Androgen Ablation for Intermediate-Risk, Localized, Adenocarcinoma of the Prostate

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Biochemical failure free-rate [ Time Frame: 1, 2, 3, 6 12, 18. 24, 30, 36 mont, 4 year and 5 year follow-up points after treatment has been completed ] [ Designated as safety issue: No ]
    To assess 5-year biochemical failure free rate (BFFR) associated with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently.


Secondary Outcome Measures:
  • Various Control Rate Assessments [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Assess biochemical, clinical, and pathologic control rates associated with the combined hypofractionated dose regimen and ADT.

  • Dose Volume/ Imaging Data Assessments [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Collect dose/volume and imaging data to allow normal tissue complication probability modeling and targeting assessment for patients treated with hypofractionated radiation therapy.

  • Biomarker Studies [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Collect whole blood to perform correlative studies for serum cytokine profiling and future biomarker studies.

  • Gastrointestinal (GI) and Genitourinary (GU toxicity) assessment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    1) Assess the incidence of grade 3 or greater GU (genitourinary) and GI (gastrointestinal) toxicity with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently.


Estimated Enrollment: 105
Study Start Date: May 2013
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiation with Androgen Deprivation Therapy (ADT)
This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT (stereotactic body radiation therapy). This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens.
Radiation: Radiation Therapy
7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions)
Drug: Androgen Deprivation Therapy (ADT)
Androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT.

Detailed Description:
This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total.
  Eligibility

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed, locally confined adenocarcinoma of the prostate
  • Patient must fit D'Amico intermediate risk criteria by clinical stage (T2b-T2c), PSA (prostatic specific antigen) (10-20 ng/mL), and/or Gleason score (Gleason 7).
  • The patient has decided to undergo external beam radiation as treatment choice for his prostate cancer.
  • Signed study-specific consent form prior to registration

Exclusion Criteria:

  • Stage T3-4 disease.
  • Gleason 8 or higher score.
  • PSA > 20 ng/ml.
  • IPSS (International Prostate Symptom Score) > 15
  • Clinical or Pathological Lymph node involvement (N1).
  • Evidence of distant metastases (M1).
  • Radical surgery for carcinoma of the prostate.
  • Previous Chemotherapy, unless intervention was greater than 5 years from beginning treatment for current prostate cancer.
  • Previous pelvic radiation therapy.
  • Previous or concurrent cancers other than basal or squamous cell skin cancers or superficial bladder cancer unless disease free for at least 5 years.
  • History of inflammatory bowel disease.
  • Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up.
  • Myocardial infarction or cerebrovascular accident within one year from consultation, or other major vascular risk factor which would prevent a patient from receiving appropriate androgen deprivation therapy.11
  • Liver function tests (LFTs) greater than twice the upper limit of normal.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01517451

Contacts
Contact: Phuoc Tran, M.D., Ph.D. 410-614-3880 tranp@jhmi.edu
Contact: Shirley DiPasquale, R.N. 410-614-1598 sdipasq1@jhmi.edu

Locations
United States, District of Columbia
Sibley Memorial Hospital Recruiting
Washington, D.C., District of Columbia, United States, 20016
Contact: Stephen Greco, M.D.    202-537-4788      
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Contact: Phuoc Tran, M.D., Ph.D.    410-614-6477      
Principal Investigator: Phuoc Tran, M.D., Ph.D.         
Sub-Investigator: Fariba Asrari, M.D.         
Sub-Investigator: Theodore DeWeese, M.D.         
Sub-Investigator: Deborah Frassica, M.D.         
Sub-Investigator: Russell Hales, M.D.         
Sub-Investigator: Danny Song, M.D.         
Suburban Hospital Recruiting
Bethesda, Maryland, United States, 20814
Contact: Stephen Greco, M.D.    866-476-1224      
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Phuoc Tran, M.D. Johns Hopkins University
  More Information

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01517451     History of Changes
Other Study ID Numbers: J11157  NA_00067963 
Study First Received: January 20, 2012
Last Updated: January 28, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Androgens
Ascorbic Acid
Estrogens, Conjugated (USP)
Methyltestosterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamins
Micronutrients
Growth Substances
Estrogens
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents

ClinicalTrials.gov processed this record on July 21, 2016